PURPOSE:The impact of the COVID-19 pandemic on the mental health of adolescents is of great concern, especially in the vulnerable group of adolescents with chronic medical conditions. The aim of this study was to examine this impact on the mental health of adolescents with chronic medical conditions treated in a German pediatric outpatient clinic. METHODS:Changes in the mental health status of adolescents with chronic medical conditions treated in a German pediatric outpatient clinic during the COVID-19 pandemic were explored via validated screening tools for anxiety and depression. RESULTS:The relative risk for adolescents with chronic medical conditions to develop clinically relevant symptoms of anxiety or depression was significantly higher (odds ratio 1,78 [confidence interval 1.06-3.04]) during the pandemic. DISCUSSION:This study identifies the COVID-19 pandemic as a potential additional risk for adolescents with chronic medical conditions to develop clinically relevant signs of anxiety or depression.
BACKGROUND:Counselling adolescents with chronic medical conditions (CMCs) can be challenging regarding suitable interviewing skills and clinicians' attitudes toward the patient. Successful communication can be a key element of treatment. Motivational Interviewing (MI) is broadly applicable in managing behavioural problems and diseases by increasing patient motivation for lifestyle changes. However, data concerning the applicability, feasibility and implementation of MI sessions in everyday practice are missing from the physicians' point of view.METHOD:The present study was conducted as a mixed methods design. Twenty paediatricians were randomized to a 2-day MI course followed by MI consultations. Data were collected through a questionnaire one year after MI training. Factors for effective training and possible barriers to successful use of MI were examined.RESULTS:Completed questionnaires were returned by 19 of 20 paediatricians. The paediatricians' experiences with MI demonstrate that MI is regarded as a valuable tool when working with adolescents with CMCs. 95% of all respondents reported that they found MI education necessary for their clinical work and were using it also outside the COACH-MI study context. 73.7% percent saw potential to strengthen the connection to their patients by using MI. The doctors were already using more MI conversation techniques after a 2-day MI course. Obstacles were seen in the short training, the lack of time and missing undisturbed environment (interruptions by telephone, staff, etc.) during clinical flow.CONCLUSIONS:MI techniques are not yet a regular part of medical training. However, a 2-day MI course was rated effective and provided a lasting impact by physicians caring for children and adolescents with chronic medical conditions (CMCs), although booster sessions should be offered regularly.TRIAL REGISTRATION:The study was registered in the German Clinical Trials Register (DRKS00014043) on 26/04/2018.
Einleitung – Patient*innen mit atopischer Dermatitis (AD) nehmen häufig Akupunktur (ACU) und osteopathische Medizin (OM) in Anspruch. Das Ziel war es, die Wirksamkeit von ACU und OM bei Patient*innen mit AD zu untersuchen. Methoden – In einer dreiarmigen, randomisiert kontrollierten, offenen, explorativen klinischen Studie erhielten Erwachsene mit AD entweder ACU, OM oder keine Studienintervention (CG), jeweils zusätzlich zur Routineversorgung. Zu den Endpunkten gehörten die Erkrankungsschwere (SCORing Atopic Dermatitis, SCORAD), die Intensität des Juckreizes (Visuelle Analogskala, VAS) und die Häufigkeit der Nutzung topischer Kortikosteroide (TCS) innerhalb von 7 Tagen. Die Endpunkte wurden mittels Kovarianzanalyse, adjustiert für den jeweiligen Baselinewert und die TCS-Nutzung, statistisch analysiert. Ergebnisse – Insgesamt wurden 121 Patient*innen (92 Frauen) mit einem Durchschnittsalter (± 14;SD) von 31,4 14;± 14;10,5 Jahren randomisiert. Nach 12 Wochen betrugen die adjustierten Mittelwerte (95 14;% KI) für ACU, OM und CG jeweils SCORAD 22,3 (18,3; 26,3), 26,4 (22,6; 30,2), 23,7 (19,9; 27,5), p = 0,321; VAS Juckreiz 27,9 (19,5; 36,4), 35,0 (26,9; 43,0), 42,3 (34,7; 50,0), p = 0,047; TCS-Nutzung 2,3 (0,8; 3,9), 1,9 (0,4; 3,5), 4,3 (2,6; 6,0), p = 0,101. Schlussfolgerung – Obwohl keine Gruppenunterschiede in der Erkrankungsschwere festgestellt wurden, deuten unsere Ergebnisse darauf hin, dass ACU den Juckreiz bei Patient*innen mit AD verringern könnte. Zudem zeigen ACU und OM eine Tendenz zur Verringerung der TCS-Nutzung. Introduction – Patients with atopic dermatitis (AD) often use acupuncture (ACU) and osteopathic medicine (OM). The aim was to investigate the effectiveness of ACU and OM in patients with AD. Methods – In a three-armed randomized controlled single-center open explorative clinical trial, adults with AD received ACU, OM, or no study intervention (CG) plus routine care each. Outcomes included disease severity (SCORing Atopic Dermatitis, SCORAD), itching intensity (Visual Analog Scale, VAS), and frequency of topical corticosteroid (TCS) use within 7 days. Endpoints were analyzed by analysis of covariance adjusted for the respective baseline value and TCS use. Results – Overall, 121 patients (92 female) with a mean (± 14;SD) age of 31.4 14;± 14;10.5 years were randomized. After 12 weeks, the adjusted means (95 14;% CI) for ACU, OM, and CG were SCORAD 22.3 (18.3; 26.3), 26.4 (22.6; 30.2), 23.7 (19.9; 27.5), p = 0.321; VAS itching 27.9 (19.5; 36.4), 35.0 (26.9; 43.0), 42.3 (34.7; 50.0), p = 0.047; TCS use 2.3 (0.8; 3.9), 1.9 (0.4; 3.5), 4.3 (2.6; 6.0), p = 0.101. Conclusion – Although no differences in disease severity were found, our findings indicate that ACU might reduce itching in patients with AD. Furthermore, ACU and OM show a trend toward reducing TCS use.
People with cystic fibrosis experience bronchopulmonary exacerbations, leading to lung damage, lung function decline, increased mortality, and a poor health-related quality of life. To date, there are still open questions regarding the rationale for antibiotic use and the optimal duration of antibiotic therapy. This prospective single-center study (DRKS00012924) analyzes exacerbation treatment over 28 days in 96 pediatric and adult people with cystic fibrosis who started oral and/or intravenous antibiotic therapy in an inpatient or outpatient setting after clinician diagnosis of bronchopulmonary exacerbation. Biomarkers of exacerbation were examined in terms of their ability to predict response to treatment and the need for antibiotic therapy. The mean duration of antibiotic therapy was 14 days. Inpatient treatment was associated with a poorer health status, but no significant difference was found in the modified Fuchs exacerbation score between inpatients and outpatients. A significant increase of in-hospital FEV1, home spirometry FEV1, and body-mass index and a significant decrease of the modified Fuchs symptom score, C-reactive protein, and 8 out of the 12 domain scores of the revised cystic fibrosis questionnaire were demonstrated after 28 days. However, a trend towards a FEV1 decline in the inpatient group on day 28 could be demonstrated, while FEV1 was maintained in the outpatient group. Correlation analyses of changes between baseline and day 28 show a strong positive correlation between home spirometry and in-hospital FEV1, strong negative correlations between FEV1 and the modified Fuchs exacerbation score and between FEV1 and C-reactive protein, and a moderately negative correlation between FEV1 and the three domains of the revised cystic fibrosis questionnaire. Responders and non-responders to antibiotic therapy were defined in terms of FEV1 improvement after therapy. A higher baseline C-reactive protein, a greater decrease in C-reactive protein, a higher baseline modified Fuchs exacerbation score, and a greater decrease in the score after 28 days could be found in the responder group, while other baseline and follow-up parameters like FEV1 showed no significant differences. Our data show that the modified Fuchs exacerbation score is applicable in a clinical setting and can detect acute exacerbations regardless of health status. Home spirometry is a useful tool for outpatient exacerbation management. A change in C-reactive protein and a modified Fuchs score change are suitable follow-up markers of exacerbation due to their strong correlation with FEV1. Further studies are needed to assess which patients would benefit from a longer duration of antibiotic therapy. C-reactive protein at exacerbation onset and C-reactive protein decline during and after therapy better predict antibiotic therapy success than FEV1 at therapy onset, while the modified Fuchs score indicates exacerbation regardless of the need for antibiotic therapy, suggesting that antibiotic therapy is only part of exacerbation management.
Background The daily demands of type 1 diabetes management may jeopardize adolescents’ mental health. We aimed to assess anxiety and depression symptoms by broad-scale, tablet-based outpatient screening in adolescents with type 1 diabetes in Germany. Methods Adolescent patients with type 1 diabetes mellitus (n = 2,394; mean age 15.4 y [SD 2.0]; 50.7% male) were screened for anxiety (GAD-7) and depression symptoms (PHQ-9) by self-report questionnaires and linked to clinical data from the DPV patient registry. Logistic regression was used to estimate the contribution of clinical parameters to positive screening results. Results Altogether, 30.2% showed a positive screening (score ≥ 7 in either test), and 11.3% reported suicidal ideations or self-harm. Patients with anxiety and depression symptoms were older (15.7 y [CI 15.5–15.8] vs. 15.3 y [CI 15.2–15.4]; p < 0.0001), had higher HbA1c levels (7.9% [CI 7.8-8.0] (63 mmol/mol) vs. 7.5% [CI 7.4–7.5] (58 mmol/mol); p < 0.0001), and had higher hospitalization rates. Females (adjusted odds ratio (aOR) 2.66 [CI 2.21–3.19]; p < 0.0001), patients > 15 years (aOR 1.40 [1.16–1.68]; p < 0.001), who were overweight (aOR 1.40 [CI 1.14–1.71]; p = 0.001), with HbA1c > 9% (> 75 mmol/mol; aOR 2.58 [1.83–3.64]; each p < 0.0001), with a migration background (aOR 1.46 [CI 1.17–1.81]; p < 0.001), or smoking (aOR 2.72 [CI 1.41–5.23]; p = 0.003) had a higher risk. Regular exercise was a significant protective factor (aOR 0.65 [CI 0.51–0.82]; p < 0.001). Advanced diabetes technologies did not influence screening outcomes. Conclusions Electronic mental health screening was implemented in 42 centers in parallel, and outcomes showed an association with clinical parameters from sociodemographic, lifestyle, and diabetes-related data. It should be integrated into holistic patient counseling, enabling early recognition of mild mental health symptoms for preventive measures. Females were disproportionally adversely affected. The use of advanced diabetes technologies did not yet reduce the odds of anxiety and depression symptoms in this cross-sectional assessment.
Einleitung – Patient*innen mit atopischer Dermatitis (AD) nehmen häufig Akupunktur (ACU) und osteopathische Medizin (OM) in Anspruch. Das Ziel war es, die Wirksamkeit von ACU und OM bei Patient*innen mit AD zu untersuchen.
BACKGROUND:Antibiotic treatment is crucial for patients with chronic bacterial infections. Suspected drug allergies often lead to inconsistent therapies and challenging clinical management for patients and caregivers. The objective of this study was to evaluate the value of lymphocyte transformation tests in comparison to skin tests for the prediction of delayed-type allergic reactions. METHODS:This prospective, observational study tested the diagnostic value of skin prick tests, intradermal tests (reading: 15 min and 72 h) and lymphocyte transformations tests for the prediction of allergic reactions in CF patients with physician reported allergy to piperacillin/tazobactam, meropenem and ceftazidime. The tests were performed directly before a 14d intravenous drug challenge. RESULTS:We performed 33 drug challenges in 29 subjects. 21 drug challenges were negative (63 %); 12 lead to a reaction (37 %), of those 2 were immediate and 10 were delayed-type. 100 % of the skin prick tests were negative. 97 % (33/34) of the intradermal tests with early reading and 100 % of the intradermal tests with late reading yielded negative results. 5/11 patients who experienced a delayed-type reaction during the drug challenge had a positive lymphocyte transformations test. All 17 patients who did not react had a negative lymphocyte transformations test. For piperacillin/tazobactam, 4/5 patients who experienced a delayed-type reaction during the drug challenge had positive lymphocyte transformations tests. Hence, for piperacillin/tazobactam, the sensitivity of the lymphocyte transformation test for prediction of reactions was 80.0 % and the specificity 100 %. CONCLUSION:We demonstrate that the lymphocyte transformation test predicts delayed-type allergy to piperacillin/tazobactam in contrast to skin tests.
Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0–100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to “in-presence” group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.
Es handelt sich um eine 14 Jahre alte Patientin, die vor 10 Jahren mit ihrer Familie aus Syrien geflohen ist und sich seit 6 Jahren in Deutschland aufhält. Die Unterbringung erfolgte in verschiedenen Flüchtlingsunterkünften. Bei der Erstuntersuchung war kein Tuberkulose-Screening bei dem Mädchen erfolgt. Seit zwei Wochen sei es zu nicht produktivem Husten, linksseitigen Thoraxschmerzen, Abgeschlagenheit und seit einer Woche zu leichtem Fieber gekommen. Ein Gewichtsverlust sei nicht aufgetreten. Die Vorstellung in unserer Klinik erfolgte bei ausbleibender Besserung unter ambulanter Amoxicillin-Therapie. Die Familien- und Eigenanamnese war unauffällig, aus der Umgebungsanamnese ergab sich kein Hinweis auf eine Tuberkulose (TB).
PURPOSE:The transition to adulthood is a challenging process for young people (YP) with chronic conditions. Patient education can help to prepare them for autonomous disease management and transfer to adult healthcare services. In a previous controlled study, participation in the youth-specific group education program ModuS-T immediately improved transition-specific knowledge, competencies, and patient activation of YP with various chronic conditions. To evaluate whether these effects are long lasting, we questioned YP from the intervention group (IG) and the control group (CG; no program) 2 years after participation. METHODS:Standardized questionnaires were used to assess YP's transition-specific knowledge, competencies, patient activation, health-related quality of life, and medical care status at baseline and 2 years later. Repeated measurement covariance analyses were used for statistical testing. RESULTS:A total of 181 YP (109 IG, 72 CG) completed the questionnaires (60% of previous interviewees; mean age 20 years, 46% female). Compared to the CG, the IG reported significant improvements in transition-specific knowledge, competencies, and patient activation (p < .001) and lower parents' responsibility for their condition (p = .004). The proportion of YP who had already transferred to adult health care was nearly the same (54% IG/56% CG), but the CG was more likely to lose access to medical care (6% IG/14% CG). There were no effects on health-related quality of life. DISCUSSION:The 1.5-day ModuS-T program has long-lasting positive effects on knowledge and competencies relevant for the transition of YP. Transition-specific patient education programs close an important care gap and should be integrated into standard care.
Patients with atopic dermatitis (AD) frequently use acupuncture (ACU) and osteopathic medicine (OM), although their therapeutic benefits are unclear.
IMPORTANCE Despite the high prevalence of anxiety and depression in youths with chronic medical conditions (CMCs), physicians encounter substantial barriers in motivating these patients to access mental health care services. OBJECTIVE To determine the efficacy of motivational interviewing (MI) training for pediatricians in increasing youths' use of mental health care. DESIGN, SETTING, AND PARTICIPANTS The COACH-MI (Chronic Conditions in Adolescents: Implementation and Evaluation of Patient-Centered Collaborative Healthcare-Motivational Interviewing) study was a single-center cluster randomized clinical trial at the University Children's Hospital specialized outpatient clinics in Dusseldorf, Germany. Treating pediatricians were cluster randomized to a 2-dayMI workshop or treatment as usual (TAU). Patient recruitment and MI conversations occurred between April 2018 and May 2020 with 6-month follow-up and 1-year rescreening. Participants were youths aged 12 to 20 years with CMCs and comorbid symptoms of anxiety and depression; they were advised by their MI-trained or untrained physicians to access psychological counseling services. Statistical analysis was performed from October 2020 to April 2021. INTERVENTIONS MI physicians were trained through a 2-day, certified MI training course; they recommended use of mental health care services during routine clinical appointments. MAIN OUTCOMES AND MEASURES The primary outcome of uptake of mental health care services within the 6-month follow-up was analyzed using a logistic mixed model, adjusted for the data's cluster structure. Uptake of mental health services was defined as making at least 1 appointment by the 6-month follow-up. RESULTS Among 164 youths with CMCs and conspicuous anxiety or depression screening, 97 (59%) were female, 94 (57%) had MI, and 70 (43%) had TAU; the mean (SD) age was 15.2 (1.9) years. Compared with patients receiving TAU, the difference in mental health care use at 6 months among patients whose physicians had undergone MI training was not statistically significant (odds ratio [OR], 1.96; 95% CI, 0.98-3.92; P =.06). The effect was moderated by the subjective burden of disease (F2,158 = 3.42; P =.04). Counseling with an MI-trained physician also led to lower anxiety symptom scores at 1-year rescreening (F1,130 = 4.11; P =.045). MI training was associated with longer conversations between patients and physicians (30.3 [16.7] minutes vs 16.8 [12.5] minutes; P <.001), and conversation length significantly influenced uptake rates across conditions (OR, 1.03; 95% CI, 1.01-1.06; P =.005). CONCLUSIONS AND RELEVANCE In this study, use of MI in specialized pediatric consultations did not increase the use of mental health care services among youths with CMCs but did lead to longer patient-physician conversations and lower anxiety scores at 1 year. Additional research is required to determine whether varying scope and duration of MI training for physicians could encourage youths with CMCs to seek counseling and thus improve integrated care models.
Background: Mental disorders often begin in the vulnerable phase of adolescence and young adulthood. Young people with chronic diseases are particularly at risk. Early recognition of mental health problems is necessary in order to be able to support those affected in a timely and adequate manner. By implementing a web-based generic screening tool for mental health in routine care, patients with juvenile idiopathic arthritis (JIA) and mental health conditions can be identified and provided with targeted treatment. Objectives: To investigate the prevalence of mental health conditions in young people with JIA in routine rheumatology care. Methods: Mental health screening is implemented as an add-on module to the National Paediatric Rheumatology Database (NPRD). The current data was gathered over a period of 24 months. Patients complete the screening tool which includes the Patient Health Questionnaire 1 (PHQ-9, score 0-27) and the Generalized Anxiety Disorder scale 2 (GAD-7, score 0-21) via a web-based questionnaire. The cut-off for critical values in PHQ-9 and GAD-7 were defined as values ≥ 10. Simultaneously, other data, such as sociodemographic data, disease activity (cJADAS10, score 0-30), functional status (CHAQ, score 0-3) were collected as well. Results: The analysis included 245 patients (75% female) with a mean age of 15.7 years and a mean disease duration of 8.8 years. 38.8% of the patients had oligoarthritis (18.0% OA, persistent/20.8% OA, extended) and 23.3% RF negative polyarthritis. At the time of documentation 49 patients (30.6%) had an inactive disease (cJADAS10 ≤ 1) and 120 (49.4%) no functional limitations (CHAQ = 0). In total, 53 patients (21.6%) had screening values in either GAD-7 or PHD-9 ≥10. Patients with critical mental health screening values showed higher disease activity and more frequent functional limitations than inconspicuous patients (cJADAS10 (mean ± SD): 9.3 ± 6 vs. 4.9 ± 4.9; CHAQ: 0.66 ± 0.6 vs. 0.21 ± 0.42). When compared to males, females were significantly more likely to report either depression or anxiety symptoms (11.7% vs. 24.9%, p = 0.031). 17.6% of all patients with valid items for these data reported to receive psychological support, meaning psychotherapeutic support (14.5%) and/or drug therapy (8.6%). Among those with a critical mental health screening score, 38.7% received psychological support (psychotherapeutic support (35.5%) and/or drug therapy (16.1%)). Conclusion: Every fifth young person with JIA reported mental health problems, however, not even every second of them stated to receive psychological support. The results show that screening for mental health problems during routine adolescent rheumatology care is necessary to provide appropriate and targeted support services to young people with a high burden of illness. References: [1]Löwe B, Unützer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. [2]Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22; 166(10):1092-7. [3]The screening data were collected as part of COACH (Conditions in Adolescents: Implementation and Evaluation of Patient-centred Collaborative Healthcare), a project supported by the Federal Ministry of Education and Research (FKZ: 01GL1740F). Disclosure of Interests: Sascha Eulert: None declared, Martina Niewerth: None declared, Jana Hörstermann: None declared, Claudia Sengler: None declared, Daniel Windschall: None declared, Tilmann Kallinich: None declared, Jürgen Grulich-Henn: None declared, Frank Weller-Heinemann Consultant of: Pfizer, Abbvie, Sobi, Roche, Novartis, Ivan Foeldvari Consultant of: Gilead, Novartis, Pfizer, Hexal, BMS, Sanofi, MEDAC, Sandra Hansmann: None declared, Harald Baumeister: None declared, Reinhard Holl: None declared, Doris Staab: None declared, Kirsten Minden: None declared
This guideline is an update from August 2020 the S2k-guideline "Atopic dermatitis" published in 2015. The reason for updating this chapter of the guideline were the current developments in the field of systemic therapy of atopic dermatitis. The agreed recommendations for systemic treatment in atopic dermatitis of the present guideline are based on current scientific data. Due to the approval of dupilumab for the treatment of moderate to severe atopic dermatitis, which cannot be treated sufficiently with topical drugs alone, this part of the guideline has now been adapted and newly consented. The indication for systemic therapy and the therapeutic response to topical and systemic treatment should be recorded and documented in a suitable form in clinic and practice. A standardized documentation of the indication for system therapy in atopic dermatitis can be recommended and is also part of the updated chapter of this guideline.
ZusammenfassungDie vorliegende Leitlinie ist eine Aktualisierung vom August 2020 zu Systemtherapeutika der 2015 publizierten AWMF‐S2k‐Leitlinie Neurodermitis. Anlass für die Aktualisierung dieses Kapitels der Leitlinie waren die aktuellen Entwicklungen zur Systemtherapie der Neurodermitis. In der vorliegenden Leitlinie sind die wissenschaftliche Datenlage und die konsentierten Empfehlungen zur Systemtherapie bei Neurodermitis aufgeführt. Aufgrund der Neuzulassung von Dupilumab für die Behandlung mittelschwer bis schwer ausgeprägter Neurodermitis, die mit topischen Medikamenten alleine nicht ausreichend behandelbar ist, wurde dieser Teil der Leitlinie jetzt angepasst und neu konsentiert. Die Indikation zur Systemtherapie und das therapeutische Ansprechen auf die topische und systemische Behandlung sollen in Klinik und Praxis in geeigneter Form erfasst und dokumentiert werden. Eine standardisierte Dokumentation der Indikation zur Systemtherapie bei Neurodermitis kann empfohlen werden und ist ebenfalls Bestandteil des hier vorliegenden aktualisierten Kapitels der Leitlinie.
Background Relatively little is known about protective factors and the emergence and maintenance of positive outcomes in the field of adolescents with chronic conditions. Therefore, the primary aim of the study is to acquire a deeper understanding of the dynamic process of resilience factors, coping strategies and psychosocial adjustment of adolescents living with chronic conditions. Methods/design We plan to consecutively recruit N = 450 adolescents (12–21 years) from three German patient registries for chronic conditions (type 1 diabetes, cystic fibrosis, or juvenile idiopathic arthritis). Based on screening for anxiety and depression, adolescents are assigned to two parallel groups – “inconspicuous” (PHQ-9 and GAD-7 < 7) vs. “conspicuous” (PHQ-9 or GAD-7 ≥ 7) – participating in a prospective online survey at baseline and 12-month follow-up. At two time points (T1, T2), we assess (1) intra- and interpersonal resiliency factors, (2) coping strategies, and (3) health-related quality of life, well-being, satisfaction with life, anxiety and depression. Using a cross-lagged panel design, we will examine the bidirectional longitudinal relations between resiliency factors and coping strategies, psychological adaptation, and psychosocial adjustment. To monitor Covid-19 pandemic effects, participants are also invited to take part in an intermediate online survey. Discussion The study will provide a deeper understanding of adaptive, potentially modifiable processes and will therefore help to develop novel, tailored interventions supporting a positive adaptation in youths with a chronic condition. These strategies should not only support those at risk but also promote the maintenance of a successful adaptation. Trial registration German Clinical Trials Register (DRKS), no. DRKS00025125 . Registered on May 17, 2021.
Background: The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 mg, daily epicutaneous peanut protein; DBV712 250 mg). Objective: We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study. Methods: Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 mg, subjects who had received DBV712 250 mg in PEPITES underwent month-36 double-blind, placebocontrolled food challenge with an optional month-38 sustained unresponsiveness assessment. Results: Of 213 eligible subjects who had received DBV712 250 mg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of >1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline;and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of >1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%). Conclusions: These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.